Reported Aug 26, 2015 · Terminated
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal…
Elite Biomedical Solutions LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elite Biomedical Solutions LLC · 5150 Fordon Ct · Cincinnati, OH · 45244-5021
Is this the product you have?
- Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
- Lot codes and dates
- P/N TC10006587 and 10013801 Lot Numbers 022015502 and 0421151000.
- Amount recalled
- 609 pieces
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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